Compliance Specialist III

Catalent; Kansas City (MO); Sur place; USD 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision benefits

8 paid holidays

Tuition reimbursement

Résumé du poste

Catalent’s Kansas City facility is seeking a Compliance Specialist III to support the preparation, review, and approval of technical and regulatory documentation onsite in Kansas City, MO. You will ensure compliance with current Good Manufacturing Practices and internal procedures, contributing to high-quality pharmaceutical operations.

Key responsibilities include authoring and reviewing protocols and batch records, maintaining lab notebooks, and ensuring readiness for on-site clients within a

Qualifications

• Bachelor’s degree in a related field or equivalent regulated-industry experience.
• Strong ability to prepare, review, and approve regulatory documents.
• Experience ensuring compliance with current Good Manufacturing Practices.

Responsabilités

• Author and approve technical documents such as protocols, reports, and SOPs.
• Review documents for accuracy and regulatory compliance.
• Review batch records for GMP conformance to SOPs and protocols.
• Draft batch records for use by pharmaceutics and operations personnel.
• Draft SOPs for processes used by pharmaceutics and operations personnel.
• Perform spot-checks of experimental areas and track lab notebooks.
• Track and trend batch record initiation, approvals, updates, and feedback after execution.
• Maintain readiness for on-site clients.
• All other duties as assigned.

Connaissances

Bachelor's degree

Microsoft Word

Microsoft Excel

Attention to detail

Regulatory compliance

Documentation

Formation

Bachelor's Degree

Outils

Microsoft Word

Microsoft Excel

Description du poste

About Site

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.

About Site

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.

Position Summary

We have an opportunity for a Compliance Specialist III to join our team. In this role, you will support the preparation, review, and approval of technical and regulatory documentation. You will ensure compliance with current Good Manufacturing Practices and internal procedures. This position offers the chance to contribute to high-quality pharmaceutical operations and continuous improvement within a dynamic environment.

Shift: Monday - Friday, 8am - 5pm

Location: Kansas City, MO

100% Onsite

The Role

• Author and approve technical documents such as protocols, reports, and operating procedures.
• Review technical documents for accuracy, thoroughness, and regulatory compliance.
• Review executed batch records and documentation to ensure conformance to appropriate current Good Manufacturing Practices, Standard Operating Procedures, and other protocols.
• Draft and review batch records for use by pharmaceutics and/or operations personnel.
• Draft Standard Operating Procedures for processes used by pharmaceutics and/or operations personnel.
• Perform spot-checks of experimental areas and assets, and track laboratory notebooks.
• Track and trend batch record initiation, approvals, updates, and feedback after execution.
• Maintain readiness for on-site clients.
• All other duties as assigned.

The Candidate

Minimum Requirements

• Bachelor’s Degree; High School Diploma or equivalent years of experience in a regulated industry.
• Ability to work effectively under pressure and meet deadlines while maintaining attention to detail, multitask, and follow a variety of instructions furnished in written, oral, diagram, or schedule form.
• Mathematical and scientific reasoning ability.
• Strong computer skills and proficiency in Microsoft Word and Microsoft Excel.
• Proactive in addressing work issues at the individual level.

Preferred Skills & Background

• None specified.

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.

Catalent offers rewarding opportunities to further your career!

Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.